Alnylam (ALNY) Q1 2026 earnings review
First Billion-Dollar Quarter Signals a New Era of Profitability
Alnylam has officially transitioned from a cash-burning biotech to a highly profitable commercial powerhouse. Driven by the blockbuster launch of AMVUTTRA in ATTR-CM, Q1 net product revenues surged 121% YoY to cross the $1 billion mark for the first time ($1.036 billion). More importantly, the company is demonstrating massive operating leverage: GAAP Net Income reversed from a $18 million loss a year ago to a $206 million profit. While rising royalty costs are compressing gross margins, and sequential TTR growth is cooling slightly, the sheer volume of the AMVUTTRA launch makes this a remarkably strong quarter. Management reiterated FY26 guidance, implying steady acceleration is still required to meet the $5.1 billion midpoint target.
🐂 Bull Case
The business model is scaling beautifully. A 121% increase in net product revenues drove a massive reversal in GAAP profitability to $206 million, proving that Alnylam's organic RNAi engine can sustainably fund itself.
AMVUTTRA revenues reached $890 million (up 187% YoY). The therapy is rapidly capturing market share, solidifying Alnylam as the undisputed leader in the underpenetrated ATTR-CM market.
🐻 Bear Case
While YoY numbers look explosive, quarter-over-quarter absolute dollar growth in the TTR franchise is decelerating. After adding $180M in 25Q3 and $134M in 25Q4, the TTR franchise only added $52M sequentially in 26Q1.
Cost of Goods Sold jumped to 20% of net product revenues, up from 15% a year ago. This 500 basis point margin compression is a direct result of higher blended royalty rates triggered by AMVUTTRA's massive sales volumes.
⚖️ Verdict: 🟢🟢
Bullish. Achieving over $1 billion in quarterly product sales and over $200 million in GAAP net income marks a definitive de-risking of Alnylam's commercial engine. The royalty headwinds are an acceptable price for this level of volume growth.
Key Themes
AMVUTTRA Powers Accelerating Top-Line Growth
The transition to AMVUTTRA is an unequivocal success. AMVUTTRA revenues hit $890 million, up 187% YoY. The drug continues to see immense patient demand in the U.S. for ATTR-CM, proving the commercial viability of RNAi therapeutics in large cardiovascular indications. This dwarfs the planned phase-out of ONPATTRO, which fell 59% YoY to $20 million as patients switch to the superior therapy.
TTR Sequential Growth is Decelerating
Despite management touting a 153% YoY growth figure for the TTR franchise, a look at the quarter-over-quarter absolute dollar additions tells a different story. The TTR segment added $180M in 25Q3, $134M in 25Q4, but only $52M in 26Q1. This deceleration contradicts the narrative of unchecked explosive growth and aligns with previous management warnings regarding Q1 headwinds from German pricing changes and U.S. annual insurance reauthorizations.
Gross Margin Compression Due to Royalty Tiers
As anticipated, Alnylam is a victim of its own success on the gross margin line. Cost of Goods Sold (COGS) as a percentage of net product revenues increased severely from 15.0% in 25Q1 to 20.0% in 26Q1. Management explicitly linked this 500 bps deterioration to higher blended royalty rates payable on the surging net sales of AMVUTTRA.
Stable Rare Disease Segment Acts as Cash Cow
The Rare Disease franchise remains a stable, decelerating but consistent growth engine. Total Rare net product revenues hit $126 million (+15% YoY). GIVLAARI grew 11% to $74 million, while OXLUMO grew 22% to $51 million. While overshadowed by TTR, this $500M+ annual run-rate business provides high-margin stability to fund pipeline development.
Pipeline Maturation and Expansion into Adipose Tissue
Alnylam's innovation engine continues to scale. In Q1, the company initiated a Phase 1 clinical trial of ALN-2232, its first adipose-targeted RNAi therapeutic (targeting ACVR1C) for obesity and weight management. Concurrently, the TRITON-CM Phase 3 study for nucresiran in ATTR-CM is enrolling so quickly that management utilized a protocol option to expand target enrollment from 1,250 to 1,750 patients, while still maintaining the ~2030 launch target.
Other KPIs
Combined R&D and SG&A expenses grew 36% YoY. While a significant jump, it is vastly outpaced by the 121% growth in net product revenues, demonstrating clear operating leverage. The R&D increase was driven by massive Phase 3 trials (ZENITH, TRITON-CM, TRITON-PN), while SG&A rose due to the ongoing global AMVUTTRA commercial launch.
Total cash, cash equivalents, and marketable securities grew from $2.9 billion at the end of 2025 to $3.0 billion at the end of 26Q1. This growth was primarily driven by net cash inflows from operating activities, further cementing the company's self-sustaining financial profile.
Guidance
Stable. Reiterated guidance implies a 64% to 77% YoY growth rate. Based on the $1.036 billion printed in Q1, the company needs to average approximately $1.35 billion per quarter for the rest of the year to hit the $5.1 billion midpoint. This implies an expectation of continued, robust sequential acceleration throughout 2026.
Stable. Reiterated guidance for the flagship franchise. Given Q1 delivered $910 million, Alnylam requires an average of roughly $1.21 billion per quarter through Q2-Q4 to reach the midpoint ($4.55B). The market will heavily scrutinize execution here to ensure the Q1 sequential deceleration was merely a seasonal blip.
Stable. Reiterated guidance reflects disciplined capital allocation. Excluding an estimated $300-$400 million in stock-based compensation, the company is successfully holding expense growth significantly below revenue growth to protect bottom-line profitability.
Key Questions
AMVUTTRA Royalty Tiers
COGS increased significantly to 20% of net product revenues due to AMVUTTRA royalty tiers. At what specific revenue threshold does the blended royalty rate cap out, and should investors view 20% as the new normalized run-rate for COGS?
TRITON-CM Enrollment Expansion
You expanded the TRITON-CM enrollment target for nucresiran from 1,250 to 1,750 patients. While enrollment is rapid, does this larger sample size imply you are hunting for a smaller statistical effect size, or is this purely to strengthen the safety database?
Q1 TTR Sequential Growth Dynamics
TTR franchise sequential dollar growth decelerated notably in Q1. How much of this was driven strictly by the anticipated Germany pricing changes versus slower U.S. patient additions, and what gives you confidence in the sequential acceleration implied by your reiterated FY26 guidance?